Application 074621

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEGESTROL ACETATE	MEGESTROL ACETATE	TABLET;ORAL	40MG	No	No
002	MEGESTROL ACETATE	MEGESTROL ACETATE	TABLET;ORAL	20MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074621-001	MEGESTROL ACETATE	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB		1995-11-30
A074621-002	MEGESTROL ACETATE	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB		1996-08-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A074621-001	AB
A074621-002	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074621-001	MEGESTROL ACETATE	40MG	TABLET / ORAL	AB	1995-11-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074621-002	MEGESTROL ACETATE	20MG	TABLET / ORAL	AB	1996-08-16	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A074621-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074621-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074621-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074621-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074621-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074621-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074621-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074621-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074621-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074621-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074621-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074621-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074621-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074621-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074621-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074621-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074621-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074621-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074621-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074621-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074621-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074621-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074621-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074621-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074621-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074621-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074621-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074621-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074621-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A074621-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074621-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074621-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074621-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A074621-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074621-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A074621-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074621-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A074621-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074621-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A074621-002	AB	1	`bb7c543d1eb4…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Megestrol Acetate	MEGESTROL ACETATE	Bryant Ranch Prepack	9b764cf3-4756-4f0e-b747-421d71674313	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074621 application number: ANDA074621
Megestrol Acetate	MEGESTROL ACETATE	Teva Pharmaceuticals USA, Inc.	66573d39-f2a7-49fd-9ed2-97ac8f6e8456	2022-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 074621 application number: ANDA074621 ndc (product): 0555-0607 ndc (product): 0555-0606

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-0606	Megestrol Acetate	Megestrol Acetate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0606	Megestrol Acetate	Megestrol Acetate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0606	Megestrol Acetate	Megestrol Acetate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0607	Megestrol Acetate	Megestrol Acetate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0607	Megestrol Acetate	Megestrol Acetate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0607	Megestrol Acetate	Megestrol Acetate	Teva Pharmaceuticals USA, Inc.	ANDA	Current
51079-434	Megestrol Acetate	Megestrol Acetate	Mylan Institutional Inc.	ANDA	Current
51079-434	Megestrol Acetate	Megestrol Acetate	Mylan Institutional Inc.	ANDA	Current